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| [ Print-friendly version ] |
| Pilot study of Homeopathic Treatment of Fibromyalgia Syndrome |
| ISRCTN | ISRCTN74040048 |
| ClinicalTrials.gov identifier | |
| Public title | Pilot study of Homeopathic Treatment of Fibromyalgia Syndrome |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N0034178702 |
| Study hypothesis | Does the addition of a homeopathy referral to usual care improve short term outcomes for patients with a diagnosis of Primary Fibromyalgia? |
| Ethics approval | Not provided at time of registration |
| Study design | Prospective pragmatic parallel group single blind randomised controlled pilot study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Musculoskeletal Diseases: Fibromyalgia |
| Participants - inclusion criteria |
1. Primary Fibromyalgia diagnoses (According to American College of Rheumatologists criteria for FMS)
2. Aged 18 years old and over 3. Score of 4 or more on FIQ pain scale (score 0-10 with 10 indicating very severe pain) at initial recruitment/assessment interview |
| Participants - exclusion criteria |
1. Pain from traumatic injury or structural disease
2. Secondary Fibromyalgia 3. Rheumatoid Arthritis 4. Inflammatory Arthritis 5. Autoimmune Disease 6. Immunosuppressant Drugs 7. Current oral steroid treatment 8. Substance abuse in last year 9. Primary psychiatric diagnosis or medication prior to onset of Fibromyalgia 10. Unstable medical or psychiatric illness 11. Chronic use of sedatives 12. Pregnant or breast feeding 13. Current acupuncture treatment 14. Homeopathic treatment in the previous three months 15. Patients not fluent in English |
| Anticipated start date | 01/01/2006 |
| Anticipated end date | 07/07/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 30 test participants, 30 controls |
| Interventions | Homeopathy referral + usual care vs usual care. |
| Primary outcome measure(s) | Difference between the Fibromyalgia Impact Questionnaire (FIQ) total score (0-80 with 0 indicating no impact), at week 22, between the experimental and control groups. |
| Secondary outcome measure(s) |
1.Short form McGill Pain Questionnaire
2. Measure Your Medical Outcomes Profile (MYMOP) 3. FIQ Pain score 4. FIQ fatigue score 5. FIQ tiredness on awakening score 6. FIQ stiffness score 7. EQ-5D Quality of life score 8. Hospital anxiety and depression scale (HAD) 9. Tender point count (Performed by blinded assessor) 10. Medication Change Questionnaire |
| Sources of funding |
Barnsley Hospital NHS Foundation Trust
BDGH Small Projects Fund |
| Trial website | |
| Publications | |
| Contact name | Dr Ade Adebajo |
| Address |
Dept of Rheumatology
Barnsley District General Hospital Gawber Road |
| City/town | Barnsley |
| Zip/Postcode | S75 2EP |
| Country | United Kingdom |
| Tel | +44 01226 777867 |
| Fax | +44 01226 202859 |
| adewale.adebajo@bhnft.nhs.uk | |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Address | The Department of Health, Richmond House, 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| Fax | +44 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 28/09/2007 |
| Last edited | 06/11/2007 |
| Date ISRCTN assigned | 28/09/2007 |
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